Currently submitted to: JMIR Research Protocols
Date Submitted: Aug 19, 2019
Open Peer Review Period: Aug 21, 2019 - Oct 15, 2019
(closed for review but you can still tweet)
NOTE: This is an unreviewed Preprint
Warning: This is a unreviewed preprint (What is a preprint?). Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn (a note “no longer under consideration” will appear above).
Peer-review me: Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period (in this case, a “Peer-Review Me” button to sign up as reviewer is displayed above). All preprints currently open for review are listed here. Outside of the formal open peer-review period we encourage you to tweet about the preprint.
Citation: Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author).
Final version: If our system detects a final peer-reviewed “version of record” (VoR) published in any journal, a link to that VoR will appear below. Readers are then encourage to cite the VoR instead of this preprint.
Settings: If you are the author, you can login and change the preprint display settings, but the preprint URL/DOI is supposed to be stable and citable, so it should not be removed once posted.
Submit: To post your own preprint, simply submit to any JMIR journal, and choose the appropriate settings to expose your submitted version as preprint.
The SEAMLESS Study: Protocol for a clinical trial evaluating a SmartphonE App-based MindfuLnEss intervention for cancer SurvivorS
Cancer patients transitioning to survivorship after completing cancer treatments need psychosocial interventions to manage stressors such as anxiety, depression, and fear of cancer recurrence. Mindfulness-based interventions (MBIs) are effective for treating these symptoms; however, cancer survivors are often unable to participate in face-to-face interventions because of difficulties such as work and family commitments, treatment-related side-effects, scheduling conflicts and geography. Smartphone app-based MBIs are an innovative way to deliver psychosocial cancer-care, and can overcome several such difficulties, since patients can participate at their own convenience. However, while hundreds of mindfulness training apps are commercially available, none have been developed specifically for and rigorously evaluated in cancer survivors.
The SEAMLESS study aims to evaluate the efficacy of a tailored app-based mindfulness intervention for cancer survivors (the Am Mindfulness-Based Cancer Survivorship –MBCS– Journey) for treating: 1) symptoms of stress (primary outcome), as well as; 2) fear of cancer recurrence, anxiety, depression, fatigue, and overall physical functioning (secondary outcomes). Additionally, the study aims to assess associations between psycho-biometric data collected by the smartphone app with self-reported outcome data from validated psychometric scales. This is the first efficacy trial of a tailored mindfulness app intervention in cancer survivors.
The study design is a randomized wait-list controlled trial, which will evaluate the effectiveness of Am MBCS for impacting the primary and secondary outcomes in cancer survivors who have completed all treatments for a minimum of 2 weeks. Outcomes will be assessed online using validated psychometric instruments delivered through the Research Electronic Data Capture (REDCap) survey software at: 1) baseline; 2) mid-intervention (2 weeks later); 3) immediately post-intervention (4 weeks); 4, 5 & 6) at 3, 6 and12 months’ post-baseline. The waitlist group will complete all assessments and will cross over to the intervention condition after the 3-month assessment. Additionally, data will be obtained by the smartphone app itself, which includes users’ engagement with the app-based intervention, their emotional state (e.g. angry, elated) from a user-inputted digital emotion-mapping board, and heart-rate data through algorithms that analyze facial bio-signals using photoplethysmography technology.
The study received ethics approval in September, 2018 and recruitment commenced in January 2019. Participants are being recruited through a provincial cancer registry, and the majority of participants currently enrolled are breast (44/83, 53%) or colorectal (17/83, 20%) cancer survivors, although some survivors of other cancer are also present. Data collection for analysis of the primary outcome will be complete by September, 2019, and follow-up data will be complete by May, 2020. Data will be analyzed to determine group differences using Linear Mixed Modelling statistical techniques.
Cancer-care providers are uncertain about the efficacy of app-based mindfulness interventions for patients, which are available in great supply in today’s digital world. This study will provide rigorously evaluated efficacy data for an app-based mindfulness intervention for cancer survivors, which if helpful, could be made easily available for psychosocial care at cancer centers worldwide.
Request queued. Please wait while the file is being generated. It may take some time.
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.